Role OverviewThe Senior Designer will work with external test houses for compliance testing of medical products, write and maintain compliance test plans and test reports, and release and manage documentation within the company’s document control system. The role requires experience with medical device compliance testing, regulatory standards, and external testing labs. The Senior Designer will also analyze changes to relevant standards and regulations, perform regulatory and compliance impact assessments on existing and new products, and develop test plans and reports.
What You Will Do
Coordinate and work with external test houses for compliance testing of medical products, write and maintain compliance test plans and test reports, release and manage documentation within the company’s document control system, analyze changes to relevant standards and regulations, perform regulatory and compliance impact assessments on existing and new products, and develop test plans and reports.
Why It Might Be a Fit
The ideal candidate will have hands-on experience with the following standards: Radio / Wireless: EN 300 328, FCC 15.247, EN 301 489 1 / EN 301 489 17, Implantable Devices: ISO 14708-1, ISO 14708-3, Non-Implantable Medical Devices: IEC 60601-1, IEC 60601-1-2, and EMC / Immunity: IEC 61000-4 series. The candidate should also be familiar with technical work instruction and drawings, and good documentation practices.
Requirements
- Medical device compliance and regulatory testing
- Test plan development and reporting
- Radio / Wireless: EN 300 328, FCC 15.247, EN 301 489 1 / EN 301 489 17
- Non-Implantable Medical Devices: IEC 60601-1, IEC 60601-1-2
- Experience working with regulatory standards and external testing labs required
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Pharmacy insurance
- Life insurance
- Accidental death & dismemberment insurance
- Disability insurance
- Employee assistance program
- 401(k) retirement plan
- 10 days of paid time off per year
- 10 paid holidays per year
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